SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

Launched by GUARDANT HEALTH, INC. · Jun 29, 2023

Keywords

ClinConnect Summary

The SIBYL trial is studying how well a new test called Guardant360 can help doctors understand how patients with advanced solid tumors, like certain types of lung, colorectal, and breast cancer, are responding to their treatments. This trial aims to gather important information about how changes in a patient’s blood can reflect their reaction to therapy. Participants will be closely monitored to see if the results from the blood tests match what doctors see on CT scans and other standard assessments.

To join the trial, participants should be adults aged 65 and older who are starting or have recently completed a specific type of cancer treatment. They need to have a confirmed diagnosis of advanced lung, colorectal, or breast cancer that cannot be surgically removed. Before enrolling, participants must provide written consent and be able to give a blood sample to help with the study. The trial is currently recruiting, and it’s a good opportunity for patients to contribute to important research that could improve cancer care in the future.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Each participant must satisfy all the following criteria to be enrolled in the study:
• • 1. Age ≥18 years old
• • 2. Are treated with systemic therapy and/or oral SOC regimen at the site of enrollment during entirety of study
• • 3. Patient is either treatment naive and has not yet commenced first line SOC therapy OR patient has completed first line SOC therapy and will commence second line of SOC therapy
• • 4. Able to understand, and capable of providing written consent to participate in the study
• • 5. Are willing to have de-identified clinical data shared with investigators at regular intervals outlined in the study protocol and informed consent
• • 6. Are willing to provide blood samples at enrollment and at subsequent clinical visits
• 7. Have a histologically confirmed Index cancer that qualifies for inclusion, defined as:
• • Cohort 1: Unresectable Stage III/IV NSCLC (\~125)
• • Cohort 2: Stage IV Colorectal (\~125)
• • Cohort 3: Unresectable Stage III/IV Breast - HR+ HER2- (\~55)
• • Cohort 4: Unresectable Stage III/IV Breast - HR- HER2+ (\~55)
• • Cohort 5: Unresectable Stage III/IV Breast - HR+ HER2+ (\~55)
• • Cohort 6: Unresectable Stage III/IV Breast - Triple Negative (\~55) Determination of stage for eligibility assessment and enrollment should be based on clinical or pathologic stage.
• • Exclusion Criteria
• Any potential participant who meets and of the following criteria at the time of initial enrollment will be excluded from participating in the study:
• • 1. History of prior solid malignancy or hematological malignancy within five years of enrollment
• • 2. Life expectancy ≤12 weeks
• • 3. Unable to collect a baseline blood sample during a SOC venipuncture, and prior to starting SOC regimen
• • 4. Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test for detecting/predicting clinical response/progression